Trends In Oxygen Saturation In Healthy Term Infants In The First Few Days Of Life: The "TOST" Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 293
- 试验地点
- 4
- 主要终点
- Measurement of Normal oxygen saturation values and their variability in the newborn period
研究概览
简要总结
Oxygen is carried in the blood attached to hemoglobin molecules. Oxygen saturation is a measure of how much oxygen hemoglobin is carrying as a percentage of the maximum it could carry. Oxygen saturation can be measured non-invasively using pulse oximetry. On occasion, term infants are admitted to the intensive care nursery for monitoring and show variability in their oxygen saturation despite appearing well. As healthy newborns do not undergo routine monitoring of oxygen saturation, health care team do not know the degree to which variability in oxygen saturation are a normal phenomenon. With increasing interest in using pulse oximetry as a screening tool to identify "at risk" newborns, it is important to have a clear understanding of postnatal oxygen saturation trends and their variability in healthy babies.
In our study, Investigators will measure oxygen saturation on healthy newborns repeatedly and for extended periods. This will allow us to describe both the variability in oxygen saturations and the pattern of changes observed in oxygen saturations over time in healthy newborns. To increase our confidence that babies included in our study were healthy at birth, they will be followed for 8 weeks to identify indicators of perinatal disease that was missed clinically. Any babies subsequently identified as having significant disease will be analyzed separately from the main cohort of healthy babies. Furthermore, the oxygen saturation readings will be obscured so as not to influence caregivers inappropriately. Lastly, pulse oximetry measurements will be performed after discharge from hospital (on day 3 to 4), potentially increasing the clinical utility of this study as it has repeatedly been stated in the literature that the sensitivity of pulse oximetry to detect important underlying disease increases significantly if performed several days after birth. This study will provide important and novel normative data.
详细描述
BACKGROUND:
The newborn period is a time of transition from the intrauterine to the extra-uterine environment. Arterial fetal oxygen saturation before birth are approximately 65%. Within minutes of delivery, and with the onset of respiration, the newborn's oxygen saturation rises close to normal postnatal values.
In practice, oxygen saturation are measured continuously using a trans-cutaneous probe connected to a pulse oximeter. The probe illuminates the local tissue and the true oxygen saturation is estimated by measuring the wavelengths of light that are not absorbed. This method of trans-cutaneous oxygen saturation measurement (SpO2) yields an accurate estimate of the true oxygen saturation comparable to measurements made via co-oximetry using whole blood (1,2).
Description of problem: Healthy newborns do not undergo routine monitoring of oxygen saturation. Hence, health care team do not know if fluctuations in oxygen saturation are a normal phenomenon. It is important to have a clear understanding of postnatal oxygen saturation trends and their variability in healthy babies to help identify infants that warrant further investigation or intervention, both in the neonatal intensive care unit (NICU) and in the "normal" newborn nursery.
Identifying "At-Risk" Newborns:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Hours 至 8 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •newborns ≥37 weeks gestation at birth
- •age between 6 to 24 hours at time of enrolment
- •admission to level 1 ("normal") nursery
- •inborn at one of the three study sites
- •the family resides within the catchment area of the Public Health Nurse program
- •Normal cardio-respiratory examination (as defined by ACORN)
排除标准
- •antenatal or postnatal diagnosis of congenital heart disease
- •pulmonary disease
- •Blood dyscrasia.
- •other major congenital abnormality
- •at risk for neonatal abstinence syndrome
- •Admission to neonatal intensive care unit or pediatric intensive care unit.
结局指标
主要结局
Measurement of Normal oxygen saturation values and their variability in the newborn period
时间窗: 8 weeks
Measurement of oxygen saturations on healthy newborns repeatedly and for extended periods. This will allow the investigators to describe both the variability in oxygen saturations and the pattern of changes observed in oxygen saturations over time in healthy newborns. To understand that babies included in the study were healthy at birth, they will be followed for 8 weeks to identify indicators of perinatal disease that was missed clinically.
次要结局
- Analysis of Oxygen saturation profiles of infants needing hospital readmission or emergency department visits.(8 weeks)
研究者
Prakash Kannan Loganathan
Fellow
University of Calgary